What began with a question of how to provide a simple solution for the critically ill patients with coronavirus, resulted in a project to support the current national and global health crisis.
The ventilator, designed by Universidad de La Sabana, is now becoming prepared for mass production. This is possible after successfully passing the tests carried out by a team of anesthesiologists, pulmonary and critical care medicine doctors in the simulation lab of the School of Medicine, as well as in the facilities of the Institute of Medical Simulation (INSIMED), where tests were carried out using biomodels..
This device is designed with low-cost and easy to obtain local and foreign elements, and can be fed with oxygen cylinders or by plugging into hospital medical gas pipeline systems. It works with electric power, has a backup battery in case of power cuts, as well as alarms and security systems that prevent human-tolerable pressures from being exceeded. All the necessary procedures and requirements from the National Institute for Food and Drug Surveillance (INVIMA) have been met. At this moment, the equipment is being prepared for mass production.
“From the scientific side, we have been preparing for this contingency for several weeks, seeking the best evidence in management guides, biosafety protocols in accordance with international guidelines, regulations, adaptation of infrastructure, logistics for hospital supplies, medications, training of people, etc. In addition, our University Hospital, as a nationally accredited institution, has the ideal task force to face this difficult situation. We have mechanical ventilation equipment available, monitoring procedures that respond to our installed capacity, support for diagnostic images, as well as an adequate clinical laboratory for timely diagnosis,” says Dr. Juan Guillermo Ortiz, General Director of the University’s Hospital (Clínica Universidad de La Sabana)
The Challenge
In the last months, the world has faced the worst sanitary crisis of recent history; COVID-19 has spread rapidly throughout the planet and has taken the healthcare systems to their limits, and Colombia is no exception. The country is expecting an accellerated increase in the number of cases of COVID-19 infected patients, where a high percentage of them will reach a critical state requiring assisted ventilation: a significant factor when it comes to saving their lives
The solution
We developed an invasive mechanical ventilator, with all functionalities required to assist a patient with severe respiratory compromise, which allows the treatment of COVID-19 infected patients.
Our solution allows ventilation to be controlled by volume, administer PEEP (Positive End Expiratory Pressure), regulate the respiratory rate, O2 concentration, inspiratory-to-expiratory time ratio, uses conventional air filters to protect patients from particles and microorganisms (including viruses); it includes graphics to monitor airway pressure and volume, as well as alarms and security systems, to detect values outside the safety range for humans.
Based on the following standards:
ISO 10651, IEC 60601, ISO 80601, AAMI TIR69, ANSI/IEEE C63.27, ISO 10993, ISO 18562, ISO 14971.